eligibility_summary
Adults 18–75 with unresectable/metastatic HER2‑positive (IHC3+ or 2+/ISH+) gastric/GEJ adenocarcinoma after progression on anti‑HER2–containing first‑line therapy, measurable disease (RECIST 1.1), ECOG 0–1, ≥12‑week survival, adequate organ function, consent. Exclude: recent therapy (<4 wks), unresolved tox >G1, active CNS mets, uncontrolled effusions, major GI/infection/immunodef, interstitial pneumonia, active HBV/HCV, significant CV disease/QTcF≥470/LVEF<50, other cancers <5 yrs, pregnancy, key drug allergies, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 RCT in HER2+ metastatic/unresectable gastric or GEJ adenocarcinoma after progression on first-line anti-HER2 therapy. Interventions: SHR-A1811—HER2-targeted antibody-drug conjugate (biologic) that binds ERBB2 on tumor cells, is internalized, and releases a cytotoxic payload to kill HER2-expressing cells and suppress HER2-driven signaling—vs investigator’s choice chemo: ramucirumab (monoclonal antibody anti-VEGFR2, anti-angiogenic) ± paclitaxel (taxane microtubule stabilizer), or paclitaxel alone, or docetaxel (taxane), or irinotecan (topoisomerase I inhibitor). Targets/pathways: HER2/ERBB2, VEGF–VEGFR2 angiogenesis, microtubules, topoisomerase I/DNA replication.